Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03063268 · ClinicalTrials.gov registry record · NA
An Interactive Patient-Centered Consent for Research Using Medical Records
A NA study, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 734
- Enrollment target
NCT03063268 is a NA study that has completed, run by University of Florida. The registered enrollment target is 734 participants.
The verdict
NCT03063268, a NA study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 734 participants
- Enrollment target
Study Summary
The goal of this project is to develop and evaluate a novel, electronic informed consent application for research involving electronic health record (EHR) data. In response to NIH RFA-OD-15-002, this study addresses research using clinical records and data, including the issues of the appropriate content and duration of informed consent and patient preferences about research use of clinical information. This study will design an electronic consent application intended to improve patients' satisfaction with and understanding of consent for research using their EHR data. The electronic application will provide interactive functionality that creates a virtual, patient-centered discussion with patients about research that uses EHR data. Also, to correct potential misconceptions and increase informedness, the application will present trust-enhancing messages that highlight facts about research regulations, researcher training, and data protections. This study (Specific Aim 2 of the linked study protocol) will compare the effectiveness of the interactive, trust-enhanced consent application to an interactive consent and standard consent (no interactivity, no trust- enhancement) using a randomized trial of the three consents with 750 adults in a network of family medicine practices. Primary outcomes will be satisfaction with the consent decision and understanding of the consent content. This application will allow patients to learn more about clinical research and make informed choices about whether or not they want their health records and data to be used for research. This first phase of this project (IRB#:201500678) was innovative because it created a virtual, patient-centered discussion about research using EHR data. Moreover, this project produced a consent application that clinicians and researchers will use in this phase (Phase two) of the trial as an ethically sound and practical tool for consenting patients, in a clinical setting, for research involving EHRs. Overa
Interventions
- BEHAVIORAL Trust-Enhanced Messaging on E-Consent
- BEHAVIORAL Interactive features on E-Consent
- BEHAVIORAL Standard E-Consent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 734 participants |
| Start Date | 2017-11-06 |
| Est. Completion | 2019-08-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03063268
The ClinicalTrials.gov registry entry for NCT03063268 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 734 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Trust-Enhanced Messaging on E-Consent is the first listed.
NCT03063268 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03063268 about?
NCT03063268 is a clinical study titled "An Interactive Patient-Centered Consent for Research Using Medical Records". The goal of this project is to develop and evaluate a novel, electronic informed consent application for research involving electronic health record (EHR) data. In response to NIH RFA-OD-15-002, this study addresses research using clinical records and data, including the issues of the appropriate co...
What is the current status of trial NCT03063268?
This trial is currently completed. It is a NA study. The enrollment target is 734 participants. The study started on 2017-11-06. Estimated completion is 2019-08-09.
What interventions are being tested in trial NCT03063268?
The interventions under investigation include: Trust-Enhanced Messaging on E-Consent (BEHAVIORAL), Interactive features on E-Consent (BEHAVIORAL), Standard E-Consent (BEHAVIORAL).
Who is sponsoring clinical trial NCT03063268?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.